Replies to post #605105 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

You are saying there was no FINAL maa submission by March 20. Most people don’t disagree with you At This Time. In a rolling review there are multiple component submissions before final submission. Some or nearly almost all of those were likely accepted before MIA certification. I don’t know why this is still being bumped around. Lykiri and Survivor received two MHRA responses on the subject.

[ATLnsider]

I do not see this as being “discombobulated”. With the further explanation and color, it is pretty straight-forward and clear.

Also, I do not see any “inexplicable delays”. I believe that is a false narrative, created by some, all across social media platforms, and used to create angst and impatience among NWBO longs.

NWBio is doing some things that have never been done before. They are trial-blazing paths that have not been travelled before. They are strategically handling BLA / MAA submissions in the US, Canada, UK, Germany and the rest of the EU.

They are on the brink of changing the way solid tumor cancer patients are treated worldwide. Starting with newly diagnosed and recurrent GBM patients. They are developing a platform treatment for all or most solid tumor cancers.

This investment is not for everyone. Especially investors who are very impatient, or who do not believe in the NWBio management team, or the DCVax science and data, or who thinks these things are easy and should happen fast.

[skitahoe]

Iron Mike, or anyone else knowledgeable about it, if a rolling review were underway, and for talking purposes there were ten parts. Let's say that now all parts were submitted, some were returned for changes, and all requested changes were made and resubmitted. At that point, if no further changes were deemed to be necessary, would they tell them they're accepting it and take further time in a final review, or would they entire package be approved and they'd notify the company they have product approval.

If my ten, or whatever part scenario is correct, it would seem to me that once all parts have been reviewed and accepted, possibly after requested changes are made, reviewed and found acceptable, the entire application should be approved.

Gary